Tasigna now approved in the US and Switzerland for this indication; regulatory
submissions under review in EU, Japan and other countries worldwide

Novartis announced today 24-month data showing that
Tasigna® (nilotinib) 150 mg capsules continues to surpass
Gleevec® (imatinib mesylate) tablets* in the treatment of
adult patients with newly diagnosed Philadelphia chromosome-positive chronic
myeloid leukemia (Ph+ CML) in chronic phase (1). These new data,
from the first Phase III comparison of the two oral therapies as
initial treatment for this blood cancer, were presented at the 52nd
Annual Meeting and Exposition of the American Society of Hematology
(ASH) in Orlando, Florida.

With this longer-term follow-up at 24 months,
first-line treatment with Tasigna at 300 mg twice daily was found
to result in a lower incidence of progression to accelerated phase
and blast crisis, compared to the standard approved dose of Gleevec
400 mg once daily. Patients receiving Tasigna also had a lower
incidence of suboptimal response and treatment failure as defined
by study criteria (1).

These data also showed that Tasigna induced deeper and
more durable complete cytogenetic response (CCyR) and major
molecular response (MMR) compared to Gleevec, as well as a
significantly higher rate of an even deeper response – a
trace amount of 0.0032% or less of the Bcr-Abl protein that causes
Ph+ CML, which is considered a complete molecular response (CMR)
(1). Fewer patients taking Tasigna in the study discontinued
treatment due to adverse events compared to Gleevec (1). Tasigna
and Gleevec were generally well tolerated.

"These 24-month Phase III data extend the evidence of
clinical benefit for newly diagnosed patients with chronic phase
Ph+ CML treated with Tasigna, compared to Gleevec," said
Timothy P. Hughes, MD, ENESTnd study
investigator and Clinical Professor at the University of
Adelaide, Australia. "Now we can
begin to evaluate the long-term treatment outcomes of patients who
achieve and maintain deep reductions in Bcr-Abl on Tasigna."

The US Food and Drug Administration (FDA) and
Swissmedic have approved Tasigna in this first-line indication. In
September, Novartis received a positive opinion from the Committee
for Medicinal Products for Human Use (CHMP) recommending European
Commission approval for Tasigna for this indication. Regulatory
submissions are under review in the European Union, Japan and other countries worldwide.

This year, Novartis also began a collaboration with
molecular diagnostics company Cepheid to develop a new FDA
cleared/approved Bcr-Abl test, which adheres to the International
Scale. The goal of the collaboration is to help doctors more
reliably monitor Ph+ CML patients. Cepheid and Novartis also will
develop a next generation test, which is expected to enable even
more sensitive testing, indicating the depth of a patient's
response to tyrosine kinase inhibitors, including Tasigna and
Gleevec. Currently there are no FDA cleared/approved tests to
monitor for Bcr-Abl.

"The creation and introduction of Gleevec
revolutionized the treatment of Ph+ CML by substantially improving
overall survival rates for patients," said Herve Hoppenot, President, Novartis Oncology. "We are encouraged by the
ongoing clinical development of Tasigna as a new treatment showing
that at 24 months it continues to surpass Gleevec in slowing
disease progression in patients with newly diagnosed chronic phase
Ph+ CML."

Another study will be presented at this year's annual
ASH meeting which provides further support for the use of Tasigna
in patients with newly diagnosed Ph+ CML. The Gruppo Italiano
Malattie Ematologiche dell'Adulto (GIMEMA) study, an ongoing,
open-label, single-stage, multicenter Phase II clinical trial, will
be presented on Monday, December 6,
2010 (2).

ENESTnd is being conducted at 217 global sites with 846
patients enrolled. Patients were randomized to receive Tasigna 300
mg twice daily (n = 282), Tasigna 400 mg twice daily (n = 281) or
Gleevec 400 mg once daily (n = 283). The primary endpoint was MMR
at 12 months; the key secondary endpoint was durable MMR at 24
months (patients having MMR when evaluated at both 12 and 24
months) (1). MMR was defined in the study as reduction in the level
of the abnormal Bcr-Abl gene to less than or equal to 0.1% of the
pretreatment level based on an internationally agreed standard (1).
Planned follow-up is for five years. Patients on the Gleevec
treatment arm who had suboptimal response or treatment failure were
allowed to escalate dose and/or switch to Tasigna via a protocol
extension. These data, presented at ASH, were the 24-month minimum
follow-up.

These data also showed that nearly three times more
patients taking Tasigna 300 mg twice daily achieved CMR –
defined as a trace amount of 0.0032% or less of the Bcr-Abl protein
that causes Ph+ CML – with Tasigna 300 mg twice daily (n
= 70) than with Gleevec (n = 25) by 24-months (1).

All patients had a minimum of 24 months of treatment or
discontinued early; the median follow-up was 25 months. Overall,
75%, 78% and 68% of patients remained in the study on Tasigna 300
mg twice daily, Tasigna 400 mg twice daily and Gleevec 400 mg once
daily, respectively (1).

Both Tasigna and Gleevec were generally well tolerated
overall. Rates of discontinuation due to adverse events or
laboratory abnormalities were 9% for Tasigna 300 mg twice daily,
13% for Tasigna 400 mg twice daily and 11% for Gleevec 400 mg once
daily (1). No patients treated with Tasigna in the study had
prolongation of QT interval >500 milliseconds (1). No sudden
deaths occurred in any of the treatment arms (1).

Chronic myeloid leukemia is a disease in which the body
produces cancerous white blood cells. Almost all patients with CML
have an abnormality known as the Philadelphia chromosome, which produces a
protein called Bcr-Abl. Bcr-Abl causes malignant white blood cells
to proliferate (3). Worldwide, CML is responsible for approximately
10% to 15% of all adult cases of leukemia (4), with an incidence of
one to two cases per 100,000 people per year (5).

About Tasigna (6)

Tasigna® (nilotinib) is indicated for the
treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic
myeloid leukemia (Ph+ CML) in chronic phase. The effectiveness of
Tasigna is based on major molecular response and cytogenetic
response rates. The study is ongoing and further data will be
required to determine long-term outcome.

Tasigna is indicated for the treatment of chronic phase
and accelerated phase Philadelphia
chromosome positive chronic myelogenous leukemia (Ph+ CML) in adult
patients resistant or intolerant to prior therapy that included
imatinib. The effectiveness of Tasigna is based on hematologic and
cytogenetic response rates. There are no controlled trials
demonstrating a clinical benefit, such as improvement in
disease-related symptoms or increased survival.

Tasigna has been approved in more than 85 countries for
the treatment of chronic phase and accelerated phase Ph+ CML in
adult patients resistant or intolerant to at least one prior
therapy, including Gleevec. The effectiveness of Tasigna for this
indication is based on hematologic and cytogenetic response rates.
There are no controlled trials demonstrating a clinical benefit,
such as improvement in disease-related symptoms or increased
survival.

Tasigna Important Safety Information

WARNING: QT PROLONGATION AND SUDDEN DEATHS

Tasigna prolongs the QT interval. Sudden deaths have
been reported in patients receiving nilotinib. Tasigna should not
be used in patients with hypokalemia, hypomagnesemia, or long QT
syndrome. Hypokalemia or hypomagnesemia must be corrected prior to
Tasigna administration and should be periodically monitored. Drugs
known to prolong the QT interval and strong CYP3A4 inhibitors
should be avoided. Patients should avoid food 2 hours before and 1
hour after taking dose. A dose reduction is recommended in patients
with hepatic impairment. ECGs should be obtained to monitor the QTc
at baseline, seven days after initiation, and periodically
thereafter, as well as following any dose adjustments.

Contraindications

Do not use in patients with hypokalemia,
hypomagnesemia, or long QT syndrome.

Warnings and Precautions

Myelosuppression

Treatment with Tasigna (nilotinib) can cause Grade 3/4
thrombocytopenia, neutropenia and anemia. Perform complete blood
counts every two weeks for the first 2 months and then monthly
thereafter, or as clinically indicated. Myelosuppression was
generally reversible and usually managed by withholding Tasigna
temporarily or dose reduction.

QT Prolongation

Tasigna prolongs the QT interval. ECGs should be
performed at baseline, seven days after initiation, periodically as
clinically indicated, and following dose adjustments. Correct
hypokalemia or hypomagnesemia prior to administration and monitor
periodically.

Significant prolongation of the QT interval may occur
when Tasigna is inappropriately taken with food, and/or strong
CYP3A4 inhibitors and/or medicinal products with a known potential
to prolong QT. Therefore, co-administration with food must be
avoided and concomitant use with strong CYP3A4 inhibitors and/or
medicinal products with a known potential to prolong QT should be
avoided. The presence of hypokalemia and hypomagnesemia may further
enhance this effect.

Sudden Deaths

Sudden deaths have been reported in patients with
resistant or intolerant Ph+ CML receiving nilotinib (n = 867;
0.6%). A similar incidence was also reported in the expanded access
program for patients with resistance or intolerant Ph+CML. The
relative early occurrence of some of these deaths relative to the
initiation of nilotinib suggests the possibility that ventricular
repolarization abnormalities may have contributed to their
occurrence.

Elevated Serum Lipase

Caution is recommended in patients with a history of
pancreatitis. In case lipase elevations are accompanied by
abdominal symptoms, doses should be interrupted and appropriate
diagnostics should be considered to exclude pancreatitis. Check
serum lipase levels monthly or as clinically indicated.

Hepatotoxicity

Serum bilirubin and hepatic
transaminases

The use of Tasigna may result in elevations in
bilirubin, AST/ALT, and alkaline phosphatase. Hepatic function
tests should be checked monthly or as clinically indicated.

Nilotinib exposure is increased in patients with
impaired hepatic function. A lower starting dose is recommended for
patients with mild to severe hepatic impairment and QT interval
should be monitored closely.

Drug Interactions

The concomitant use of QT prolonging drugs and strong
inhibitors or inducers of CYP3A4 should be avoided as they may
affect serum concentration of Tasigna.

Concomitant strong CYP3A4 inhibitors

The concomitant use of strong CYP3A4 inhibitors or
anti-arrhythmic drugs (including, but not limited to amiodarone,
disopyramide, procainamide, quinidine and sotalol) and other drugs
that may prolong QT interval (including, but not limited to
chloroquine, clarithromycin, haloperidol, methadone, moxifloxacin,
and pimozide) should be avoided. Should treatment with any of these
agents be required, it is recommended that therapy with Tasigna be
interrupted. If interruption of treatment with Tasigna is not
possible, patients who require treatment with a drug that prolongs
QT or strongly inhibits CYP3A4 should be closely monitored for
prolongation of the QT interval. If patients must be
co-administered a strong CYP3A4 inhibitor, based on pharmacokinetic
studies, consider a dose reduction to 300 mg once daily in patients
with resistant or intolerant Ph+ CML or to 200 mg once daily in
patients with newly diagnosed Ph+ CML-CP. If the strong inhibitor
is discontinued, a washout period should be allowed before Tasigna
is adjusted upward to the indicated dose. Close monitoring for
prolongation of the QT interval is indicated for patients who
cannot avoid strong CYP3A4 inhibitors. Grapefruit products and
other foods that are known to inhibit CYP3A4 should also be
avoided.

Concomitant strong CYP3A4 inducers

The concomitant use of strong CYP3A4 inducers should be
avoided (including, but not limited to, dexamethasone, phenytoin,
carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital).
Patients should also refrain from taking St John's Wort.
Based on the nonlinear pharmacokinetic profile of nilotinib,
increasing the dose of Tasigna when co-administered with such
agents is unlikely to compensate for the loss of exposure. Tasigna
is a competitive inhibitor of CYP3A4, CYP2C8, CYP2C9, CYP2D6, and
UGT1A1. In vitro studies also suggest that nilotinib may induce
CYP2B6, CYP2C8 and CYP2C9, and decrease the concentrations of drugs
which are eliminated by these enzymes. Single-dose administration
of Tasigna to healthy subjects did not change the pharmacokinetics
and pharmacodynamics of warfarin (a CYP2C9 substrate). The ability
of Tasigna to induce metabolism has not been determined in vivo.
Caution should be exercised when co-administering Tasigna with
substrates for these enzymes that have a narrow therapeutic index.
Tasigna inhibits human P-glycoprotein. If Tasigna is administered
with drugs that are substrates of Pgp, increased concentrations of
the substrate are likely and caution should be exercised.

Proton pump inhibitors

Since proton pump inhibitors affect pH of the upper GI
tract for an extended period, separation of doses may not eliminate
the interaction, The concomitant use of proton pump inhibitors with
Tasigna should be used with caution.

Food Effects

Food increases blood levels of Tasigna. Patients should
avoid food 2 hours before and at least one hour after
the dose is taken.

Total Gastrectomy

The exposure of nilotinib is reduced in patients with
total gastrectomy. More frequent follow-up of these patients
should be considered. Dose increase or alternative therapy may be
considered in patients with total gastrectomy.

Lactose

Since the capsules contain lactose, Tasigna is not
recommended for patients with rare hereditary problems of galactose
intolerance, severe lactose deficiency with a severe degree of
intolerance to lactose-containing products, or of glucose-galactose
malabsorption.

Use in Pregnancy

There are no adequate and well-controlled studies of
Tasigna in pregnant women. However, Tasigna may cause fetal
harm when administered to a pregnant woman. Women of child-bearing
potential should avoid becoming pregnant while taking Tasigna and
should be advised of the potential hazard to the fetus if they
do.

Tasigna may need to be temporarily withheld and/or dose
reduced for QT prolongation, hematological toxicities that are not
related to underlying leukemia, clinically significant moderate or
severe nonhematologic toxicities, laboratory abnormalities, or
concomitant use of strong CYP3A4 inhibitors.

For Grade 3 to 4 lipase elevations, dosing should be
withheld, and may be resumed at 400 mg once daily. For Grade 3 to 4
bilirubin or hepatic transaminase elevations, dosing should be
withheld, and may be resumed at 400 mg once daily.

Hepatic impairment

If possible, consider alternative therapies. If Tasigna
must be administered to patients with hepatic impairment, a lower
starting dose is recommended in patients with hepatic impairment
and QT interval should be monitored. The following dose reduction
should be considered:

For patients with mild (Child-Pugh Class A) or moderate
(Child-Pugh Class B) hepatic impairment, an initial dosing regimen
of 300 mg twice daily followed by dose escalation to 400 mg twice
daily based on tolerability should be considered. For patients with
severe hepatic impairment (Child-Pugh Class C), a starting dose of
200 mg twice daily followed by a sequential dose escalation to 300
mg twice daily and then to 400 mg twice daily based on tolerability
should be considered.

Other Patients in whom Tasigna Should be Used with
Caution

Tasigna should not be used during pregnancy. Sexually
active female patients should use effective contraception during
treatment. Women should not breast feed while taking Tasigna. The
safety and effectiveness of Tasigna in pediatric patients have not
been established.

Please see accompanying full prescribing
information.

About Gleevec (7)

Gleevec® (imatinib mesylate) tablets are indicated
for newly diagnosed adult patients with Philadelphia chromosome–positive chronic
myeloid leukemia (Ph+ CML) in the chronic phase (CP). Gleevec is
also indicated for the treatment of patients with Ph+ CML in blast
crisis (BC), accelerated phase (AP), or in CP after failure of
interferon-alpha therapy.

Who Should Not Take Gleevec

Gleevec should not be taken by women who are or could
be pregnant. Fetal harm can occur when administered to pregnant
women; therefore, women should not become pregnant, as well as be
advised of the potential risk to the unborn child if Gleevec is
used during pregnancy. Gleevec should also not be taken by women
who are breast-feeding because of the potential for serious adverse
reactions in nursing infants. Sexually active females should use
adequate birth control while taking Gleevec.

Be sure to talk to your doctor and/or healthcare
professional about these issues before taking Gleevec.

Warnings and Precautions

Gleevec is often associated with edema (swelling) and
serious fluid retention. It is important that patients be weighed
and monitored regularly for signs and symptoms of serious fluid
retention, or unexpected weight gain. Patients experiencing
unexpected rapid weight gain should speak to their doctor about
appropriate supportive care treatment. Studies have shown that
edema (swelling) tended to occur more often among patients who are
65 and older or those taking higher doses of Gleevec. If you
experience severe fluid retention, your doctor may stop your
treatment with Gleevec until the fluid retention has been
managed.

Cytopenias (reduction or lack of certain cell elements
in blood circulation), such as anemia, have occurred. Your doctor
will perform complete blood counts weekly for the first month,
biweekly for the second month, and periodically thereafter. In most
cases, your doctor will reduce or interrupt your Gleevec therapy;
in rare cases, your doctor may discontinue treatment. If the
cytopenia is severe, your doctor may reduce your dose or
temporarily stop your treatment with Gleevec.

Severe congestive heart failure and left ventricle
dysfunction have been reported, particularly in patients with other
health issues and risk factors. Patients with heart disease or risk
factors will be monitored and treated for the condition.

Severe liver problems (hepatotoxicity) may occur. Your
doctor will check your liver function before beginning treatment
and continue to monitor liver function as needed. If you experience
severe liver problems, your doctor may stop your treatment with
Gleevec until the liver problem has been managed.

Bleeding may occur. Severe gastrointestinal (GI)
bleeding has been reported in patients with Ph+ CML.

In patients with hypereosinophilic syndrome (a
condition with increased eosinophils, which are a type of white
blood cell) and heart involvement, cases of heart disease
(cardiogenic shock/left ventricular dysfunction) have been
associated with the initiation of Gleevec therapy. Speak to your
doctor regarding appropriate supportive care or discontinuing
Gleevec.

Skin reactions, such as fluid-filled blisters, have
been reported with the use of Gleevec.

Long-term use may result in potential liver, kidney,
and/or heart toxicities; immune system suppression may also result
from long-term use.

Gleevec can cause fetal harm when administered to a
pregnant woman. Women should be aware of the potential harm to the
fetus. Be sure to inform your doctor if you are or think you may be
pregnant. You should not breast-feed while taking Gleevec.

GI perforation (small holes or tears in the walls of
the stomach or intestine), in some cases fatal, has been
reported.

Gleevec Important Safety Information

The following serious side effects have been reported
in patients taking Gleevec: severe fluid retention, (which can
cause swelling around the eyes or swelling of the lower legs,
lungs, and heart; fatal in rare cases), increased pressure in the
heart or brain (fatal in rare cases), low levels of certain blood
cells, heart failure/cardiogenic shock, liver problems, hemorrhage
(abnormal bleeding), skin blistering and low levels of thyroid
hormone.

Your doctor will check you closely for any side effects
to stop more serious complications from occurring. Patients with
heart disease or risk factors for heart failure should also be
monitored carefully.

Gleevec is sometimes associated with stomach or
intestinal irritation. Gleevec should be taken with food and a
large glass of water to minimize this problem. There have been rare
reports, including deaths, of stomach or intestinal perforation (a
small hole or tear).

If you are experiencing any of the above-mentioned side
effects, please be sure to speak with your doctor immediately.

Common Side Effects of Gleevec

Almost all patients treated with Gleevec experience
side effects at some time. Most side effects are mild to moderate
in severity. Some common side effects you may experience include
fluid retention, muscle cramps or pain and bone pain, vomiting,
diarrhea, decreased hemoglobin, nausea, fatigue, rash and anorexia
(loss of appetite).

If you are experiencing any of the above-mentioned side
effects, please be sure to speak with your doctor immediately.

The severity of some side effects may be reduced with
the help of other medicines and advice from your doctor, while
others may require stopping Gleevec therapy for a while or changing
the dose. However, in some cases, Gleevec therapy may need to be
discontinued.

Tell your doctor if you experience side effects during
therapy with Gleevec, including fever, shortness of breath, blood
in your stools, jaundice (yellowing of the skin and/or eyes),
sudden weight gain, symptoms of heart failure, or if you have a
history of heart disease or risk factors for heart disease.

After the approval of Gleevec, the following adverse
events have been reported in patients treated with Gleevec:
compression of the heart due to increased fluid, swelling of the
brain, GI perforation (holes in the stomach or intestine), and
sudden lung failure. These events, including some fatalities, may
or may not have been drug related.

Take Gleevec exactly as prescribed. Do not change your
dose or stop taking Gleevec unless you are told to do so by your
doctor. If you miss a dose, take your dose as soon as possible,
unless it is almost time for your next dose. In this case, your
missed dose should not be taken. A double dose should not be taken
to make up for any missed dose. You should take Gleevec with a meal
and a large glass of water.

Do not take any other medications without talking to
your doctor or pharmacist first, including over-the-counter
medications such as Tylenol® (acetaminophen); herbal products
(St. John's wort, Hypericum
perforatum); Coumadin® (warfarin sodium); rifampin;
erythromycin; metoprolol; ketoconazole; and Dilantin®
(phenytoin). Taking these with Gleevec may affect how they work, or
affect how Gleevec works.

You should also tell your doctor if you are taking or
plan to take iron supplements. Patients should also avoid
grapefruit juice and other foods that may affect how Gleevec
works.

Tylenol (acetaminophen) is a registered trademark of
McNeil Consumer & Specialty Pharmaceuticals, a division of
McNeil PPC, Inc. Coumadin (warfarin sodium) is a registered
trademark of Bristol-Myers Squibb Company. Dilantin (phenytoin) is
a registered trademark of Parke-Davis, a division of Pfizer
Inc.

*For more detailed study information, please see full
Prescribing Information.

The foregoing release contains forward-looking
statements that can be identified by terminology such as "under
review," "expected," "goal," or similar expressions, or by express
or implied discussions regarding potential new indications or
labeling for Tasigna or regarding potential future revenues from
Tasigna or Gleevec. You should not place undue reliance on these
statements. Such forward-looking statements reflect the current
views of management regarding future events, and involve known and
unknown risks, uncertainties and other factors that may cause
actual results with Tasigna or Gleevec to be materially different
from any future results, performance or achievements expressed or
implied by such statements. There can be no guarantee that Tasigna
will be approved for any additional indications or labeling in any
market. Nor can there be any guarantee that Tasigna or Gleevec will
achieve any particular levels of revenue in the future. In
particular, management's expectations regarding Tasigna and Gleevec
could be affected by, among other things, unexpected regulatory
actions or delays or government regulation generally;
unexpected clinical trial results, including unexpected new
clinical data and unexpected additional analysis of existing
clinical data; the company's ability to obtain or maintain patent
or other proprietary intellectual property protection; competition
in general; government, industry and general public pricing
pressures; the impact that the foregoing factors could have on the
values attributed to the Novartis Group's assets and liabilities as
recorded in the Group's consolidated balance sheet, and other risks
and factors referred to in Novartis AG's current Form 20-F on file
with the US Securities and Exchange Commission. Should one or more
of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially
from those anticipated, believed, estimated or expected. Novartis
is providing the information in this press release as of this date
and does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new
information, future events or otherwise.

About Novartis

Located in East Hanover, New
Jersey, Novartis Pharmaceuticals Corporation is an affiliate
of Novartis AG, which provides healthcare solutions that address
the evolving needs of patients and societies. Focused solely on
healthcare, the Novartis Group offers a diversified portfolio to
best meet these needs: innovative medicines, preventive vaccines,
diagnostic tools, cost-saving generic pharmaceuticals and consumer
health products. The Novartis Group is the only company with
leading positions in each of these areas. In 2009, the Group's
continuing operations achieved net sales of USD 44.3 billion, while approximately
USD 7.5 billion was invested in
R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group
companies employ approximately 100,000 full-time-equivalent
associates and operate in more than 140 countries around the world.
For more information, please visit http://www.us.novartis.com.

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